MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PLS HARNESS SET CP

Model Number	00620-CP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Local Reaction (2035); Nasal Obstruction (2466); Swelling/ Edema (4577)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tubing harness is the only component of the plasma harness set that is eto sterilized.Haemonetics obtained device history record for the lot of the reported plasma harness set, sterilization parameters were within specification and within validated parameters.The sample was not available for return to hameonetics for evaluation.Without a physical sample the root cause cannot be determined.
Event or Problem Description
On december 30, 2020 haemonetics was notified of a donor reaction that fit the description of an ethylene oxide reaction which occurred on the process phase during a procedure, utilizing the pcs®2 plasma collection system and plasma harness set.The reaction occurred during saline infusion, the donor experienced periorbital swelling, nasal congestion and eye watering.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Common Device Name: PLS HARNESS SET CP
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11207571
• Report Number: 1219343-2020-00160
• Device Sequence Number: 4162996
• Product Code: GKT
• UDI-Device Identifier: 10812747011761
• UDI-Public: (01)10812747011761(17)230411(10)200412511
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK040025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: 00620-CP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other